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临床试验/NCT00132184
NCT00132184Unknown2 期

Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation

University of Aarhus8 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2005年9月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
110
试验地点
8
主要终点
Relapse rate within 1 year treatment; CDAI>220

研究概览

简要总结

The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

详细描述

Crohns Disease is an inflammatory disease of primarily the small intestine and colon.

In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Crohn's disease
  • Inactive Crohn's disease for at least 4 weeks
  • Crohn's Disease Activity Index (CDAI) < 150
  • C-reactive protein within normal range
  • Serum albumin within normal range

排除标准

  • Hypercalcemia
  • Short bowel syndrome
  • Pregnancy

结局指标

主要结局

Relapse rate within 1 year treatment; CDAI>220

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (8)

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